PRECeDe Pilot: Prevention of neonatal respiratory distress with antenatal corticosteroids before elective caesarean section in women with diabetes - a feasibility randomised trial

Abstract

Objective: The PRECeDe Pilot Trial was designed to determine the feasibility of undertaking a multicentre, randomised controlled trial (RCT) to assess the efficacy of antenatal corticosteroids administration within 7 days before elective caesarean section (CS) in women with pre-gestational diabetes (PGDM) or gestational diabetes (GDM).

Design: Triple blind, parallel group, placebo-controlled, pilot RCT.

Setting: Single-centre tertiary maternity hospital in Melbourne, Australia.

Population: Pregnant women with PGDM (type 1 or type 2 diabetes) or GDM booked for a planned CS scheduled between 35⁺⁰ and 38⁺⁶ weeks of gestation.

Methods: Eligible participants were randomised to receive two injections of either betamethasone 11.4 mg or normal saline placebo, 24 hours apart within 7 days before CS scheduled between 35⁺⁰ and 38⁺⁶ weeks of gestation.

Main outcome measure: The proportion of eligible women who consented and were randomised.

Trial registration: Australian and New Zealand Clinical Trials Registry ACTRN12619001475134.

Results: Of 537 women eligible, 182 were approached and 47 (26%) were recruited. Of these, 22 were allocated to the betamethasone group and 25 were allocated to the placebo group. There were no serious adverse events related to participation.

Conclusion: It is feasible to undertake a triple-blind, placebo-controlled RCT investigating the efficacy of antenatal corticosteroids in preventing respiratory morbidity in infants of women with PGDM or GDM who are undergoing an elective CS between 35⁺⁰ and 38⁺⁶ weeks.

Keywords: antenatal corticosteroids; betamethasone; caesarean section; diabetes; gestational diabetes; neonatal hypoglycaemia; respiratory distress syndrome.